LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K211688
    Device Name
    DC-Air and Athlos-1 and Athlos-Air
    Manufacturer
    Athlos Oy
    Date Cleared
    2021-07-22

    (50 days)

    Product Code
    MUH
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Athlos Oy

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DC-Air™, Athlos-1, Athlos-Air are intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw, and oral structures. DC-Air™, Athlos-1, Athlos-Air are suitable for general populations.
    Device Description
    The subject device DC-Air™ (also known as Athlos-Air) is a wireless intraoral digital X-ray system that comprises of three (3) main components: - (1) An intraoral X-ray image detector (sensor) with rechargeable battery for capturing X-ray images and which connects to the docking station via a wireless communications protocol (Bluetooth 5.0), - (2) A docking station that acts as the receiver of the data (X-ray image) sent by the detector and which forwards the data to the operator's personal computer (PC) via USB connection. Also, the docking station functions as a charging station of the detector, and - (3) An Imaging Software package.
    Ask a Question

    Page 1 of 1